Syntara’s SNT-5505 Faces Crucial FDA Talks After Promising Interim Data
Syntara Limited reports encouraging interim Phase 2 data for its drug SNT-5505 combined with ruxolitinib, demonstrating significant symptom relief and spleen volume reduction in myelofibrosis patients. The company plans to engage the FDA soon to discuss pivotal trial design.
- 73% of evaluable patients achieved significant symptom improvement at 24 weeks
- 44% of patients showed meaningful spleen volume reduction without increasing ruxolitinib dose
- SNT-5505 demonstrated a strong safety profile with no treatment-related serious adverse events
- Final Phase 2 results expected in Q3 2025 after all patients complete 52 weeks
- Syntara to engage FDA on pivotal Phase 2c/3 trial design and pursue global partnerships
Positive Momentum in Myelofibrosis Treatment
Syntara Limited (ASX, SNT), a clinical-stage biotech company, has unveiled promising interim results from its ongoing Phase 2 trial of SNT-5505, a novel drug candidate targeting myelofibrosis (MF). The data, to be presented at the European Hematology Association conference, builds on encouraging findings shared late last year, reinforcing the potential of SNT-5505 as an add-on therapy for patients with suboptimal response to current standard treatments.
Clinical Benefits and Safety Profile
The trial enrolled 16 patients with intermediate-2 or high-risk MF, all previously treated with ruxolitinib for an average of three years. Among evaluable patients, 73% achieved at least a 50% reduction in symptom burden at 24 weeks or beyond, with symptom improvements deepening over time, reaching a 63% mean reduction at 52 weeks for those completing the full treatment course. Additionally, 44% of patients experienced a meaningful 25% or greater reduction in spleen volume, a key clinical marker, without any increase in ruxolitinib dosage, underscoring the additive effect of SNT-5505.
Importantly, the drug demonstrated a strong safety and tolerability profile, with no treatment-related serious adverse events reported. Hematological parameters such as hemoglobin and platelet counts remained stable, and some patients showed reduced transfusion needs or improved blood counts, suggesting potential benefits beyond symptom control.
Strategic Next Steps and Regulatory Engagement
With three patients still completing the 52-week treatment phase, Syntara anticipates reporting final Phase 2 results in the third quarter of 2025. The company plans to engage with the U.S. Food and Drug Administration (FDA) shortly thereafter to discuss these results and the design of a pivotal Phase 2c/3 trial. This regulatory dialogue, coupled with ongoing discussions with potential global partners, positions Syntara to accelerate development and potentially bring a differentiated therapy to market for a patient population with limited options.
Broader Pipeline and Market Context
SNT-5505’s unique mechanism of action and its compatibility with JAK inhibitors like ruxolitinib could mark a significant advancement in MF treatment, a disease characterized by debilitating symptoms and poor prognosis. Syntara’s broader pipeline also targets fibrotic and inflammatory diseases, leveraging its expertise in amine oxidase chemistry. The recent Fast Track designation by the FDA for SNT-5505 further underscores the potential impact of this therapy.
CEO Gary Phillips highlighted the durability of responses and the drug’s safety as key differentiators, expressing optimism about upcoming regulatory discussions and partnership opportunities. As the company moves closer to pivotal trial initiation, investors and the medical community will be watching closely for confirmation of these encouraging trends.
Bottom Line?
Syntara’s advancing clinical program and regulatory engagement set the stage for a pivotal trial that could reshape treatment for myelofibrosis patients.
Questions in the middle?
- Will the final Phase 2 results confirm the durability and magnitude of symptom and spleen improvements?
- How will the FDA respond to the proposed pivotal trial design and Fast Track designation?
- What partnerships might Syntara secure to support global development and commercialization?
